Health Care Watch: January 13, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from January 7 – January 14. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On January 8, Speaker Mike Johnson (R-LA) and Senate Majority Leader Chuck Schumer (D-NY) reached an agreement on top-line government funding that would amount to a less than 1% cut from current non-defense funding. This agreement drew opposition from Freedom Caucus members. On January 14, House and Senate leadership announced an agreement to continue the laddered approach to funding the government through March 1 and March 8. Current government funding will expire on January 19 and February 2.
On January 8 and 9, Dr. Anthony Fauci participated in a closed-door testimony before the Select Committee on the Coronavirus Pandemic. A major topic during the hearing was Dr. Fauci’s definition of gain of function, which he says aims to make viruses more transmissible to better examine them. Fauci declined to comment on the hearings, but lawmakers said he agreed to testify in a future open session.
On January 9, Energy & Commerce Committee members Reps. Larry Bucshon (R-IN) and Greg Pence (R-IN) announced they will not seek reelection.
Senate
On January 7, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) sent letters to the four largest domestic inhaler manufactures. Letters were sent to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva Pharmaceuticals requesting information on production of inhalers, patient assistance programs and patents. The letters come as Chairman Sanders launches an investigation into the rising prices of inhalers.
REGULATORY UPDATE
On January 8, the Food & Drug Administration (FDA) announced that it now considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices. FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization.
On January 8, Department of Health & Human Services (HHS) Secretary Xavier Becerra appointed Stacy Sanders to the role of Chief Competition Officer, a new role for the Department which was created last month as part of the Biden-Harris Administration’s efforts to lower health care and prescription drugs costs by promoting competition. Ms. Sanders oversees the Department's implementation of the Inflation Reduction Act, long-term care initiatives, policies to promote health care competition, and other Medicare work. As Chief Competition Officer, Ms. Sanders will be responsible for coordinating, identifying, and elevating opportunities across the Department to promote competition in healthcare markets.
On January 9, the Centers for Medicare & Medicaid Services (CMS) approved an amendment to New York’s Medicaid section 1115 demonstration that bundles a series of actions to advance health equity and strengthen access to primary and behavioral health care across the state. CMS’ approval allows New York to make large investments in wide-ranging Medicaid initiatives, including establishing sustainable base rates for safety net hospitals that serve the state’s most underserved communities; connecting people to critical housing and nutritional support services; enhancing access to coordinated and comprehensive treatment for substance use disorders (SUDs); and making long-term, sustainable investments in the state’s health care workforce.
On January 9, FDA released its new drug therapy approvals report for 2023. The report provides a summary of FDA’s Center for Drug Evaluation and Research’s (CDER) approved drug therapies. The agency approved 55 novel drugs in 2023.
On January 9, FDA issued a priority review voucher to Vertex Pharmaceuticals for sponsoring its sickle cell therapy Casgevy.
On January 9, HHS’ Office for Civil Rights (OCR) released a final rule, entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes. The final rule clarifies the process for enforcing federal conscience laws and strengthens protections against conscience and religious discrimination by partially rescinding a 2019 rule entitled Protecting Statutory Conscience Rights in Health Care; Delegations of Authority. A fact sheet detailing the final rule can be found here.
On January 9, HHS Secretary Becerra met virtually with pharmacy leaders, pharmacy benefit managers (PBMs), and insurers to discuss HHS’ continued commitment to increasing equitable access to COVID-19 therapeutics. During the call, Secretary Becerra reminded participants that no patient should be forced to pay the full out-of-pocket cost to access Paxlovid and asked that stakeholders immediately alert HHS of any issues that arise regarding COVID-19 therapeutics access. Secretary Becerra reiterated HHS’ commitment to ensuring smooth access to oral antivirals for COVID-19 and encouraged all providers to ensure patients who experience issues accessing Paxlovid or Lagevrio are directed to the designated patient assistance programs available for both antivirals.
On January 9, the Advanced Research Projects Agency for Health (ARPA-H) announced a new program to increase investment in addressing preventable health challenges in underserved communities. The Health care Rewards to Achieve Improved Outcomes (HEROES) program will aim to spur investment in community-level preventative care resources, especially in communities that have long experienced limited access to breakthroughs in medicine and health care. ARPA-H is currently looking to engage with groups central to establishing its incentive-based approach, including Health Accelerators, investors, and organizations with a business stake in improving public health. Interested groups can learn more about how to engage with the agency here.
On January 9, FDA Commissioner Robert Califf announced that Elizabeth Jungman will serve as his next chief of staff. Jungman, who currently leads the agency’s Office of Regulatory Policy, will start her new duties January 28, 2024.
On January 10, CMS announced that over 20 million people have selected an Affordable Care Act (ACA) Health Insurance Marketplace plan since the 2024 Marketplace Open Enrollment Period launched on November 1 — a record number of enrollments. Total plan selections include more than 3.7 million people (18% of total) who are new to the Marketplaces for 2024, and 16.6 million people (82% of total) who had active 2023 coverage and selected a plan for 2024 coverage or were automatically re-enrolled.
On January 10, CMS announced that it will host a Medicare Ground Ambulance Data Collection System (GADCS) Overview Webinar on January 18 from 2:00 – 3:30 PM ET. The webinar will provide an overview of ground ambulance organizations in Years 3 and 4 as they start reporting Medicare GADCS data to CMS in 2024. Registration for the webinar can be found here.
On January 10, FDA announced that it will temporarily allow French manufacturer Laboratories Delbert to import their drug Extencilline, a version of penicillin, used to treat syphilis.
On January 11, HHS launched a new, online hub for partners to access critical Medicaid and Children’s Health Insurance Program (CHIP) renewal and transition resources. The outreach and engagement resource hub pulls together materials from across the federal government. The webpage features communications materials and toolkits in various languages and includes materials to reach different populations including by state, for people in rural areas, and various racial and ethnic communities.
On January 11, ARPA-H announced the Transplantation of Human Eye Allografts (THEA) program, which intends to transplant whole human eyes to restore vision for the blind and visually impaired. To accomplish eye transplant surgery and healing, THEA will leverage emerging microsurgical techniques, coupled with genetic and cell-based therapies, to preserve or regrow nerves from the eye to the brain. Multiple awards under this solicitation are anticipated.
WHITE HOUSE
On January 11, the Biden Administration convened a meeting with manufacturers of respiratory syncytial virus (RSV) immunizations for infants, including Sanofi and AstraZeneca, to receive an update on supply, and to underscore the need for manufacturers to continue efforts to meet current and projected demand through the commercial market. Senior Administration officials and manufacturers pledged to continue conversations on the importance of proactively planning to increase availability, and to take steps now to meet projected demand for the 2024-25 viral season.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
Advance Notice of Methodological Changes for Calendar Year 2025 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies & Draft CY 2025 Part D Redesign Program Instructions; Proposed Rule; 12/1/23
Disproportionate Share Hospital (DSH) Third Party Payer (CMS-2445); Final Rule; 12/8/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule’ 12/19/23
Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (CMS-2439); Final Rule; 12/20/23
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Revised Draft Guidance for Industry (CDER, 2023-36); Notice; 12/1/23
OCR
Confidentiality of Substance Use Disorder Patient Records; Final Rule; 12/4/23
REPORTS
Office of Inspector General (OIG)
On January 9, OIG released a report examining Oklahoma nursing home compliance with federal requirements for life safety, emergency preparedness, and infection control. OIG found that Oklahoma could better ensure that nursing homes in Oklahoma that participate in the Medicare or Medicaid programs comply with Federal requirements for life safety, emergency preparedness, and infection control if additional resources were available. OIG identified deficiencies related to life safety, emergency preparedness, or infection control at all 20 nursing homes that were audited, totaling 146 deficiencies. Specifically, OIG found 98 deficiencies related to life safety, 16 deficiencies related to emergency preparedness, and 32 deficiencies related to infection control. As a result, the health and safety of residents, staff, and visitors at the 20 nursing homes were at an increased risk. OIG recommends that Oklahoma follow up with the 20 nursing homes in the audit to ensure that they have taken corrective actions.
UPCOMING HEARINGS
Senate
HELP Committee
January 18; 10:00 AM; SD-430
Addressing Long COVID: Advancing Research and Improving Patient Care
January 25; 10:00 AM
Why Does the United States Pay, By Far, The Highest Prices in the World for Prescription Drugs?
OTHER POLICY NEWS
On January 9, the Federal Trade Commission (FTC) reached a settlementwith Outlogic, a location data broker that had been collecting information on people’s visits to medical centers. The settlement is the first major enforcement on location data since a 2022 executive order directed the government to ramp up privacy protections for anyone seeking an abortion. The settlement resulted in the FTC banning Outlogic from selling people’s sensitive location information.
On January 11 and 12, MedPAC held its January meetings. Commissioners voted on a variety of draft recommendations on topics such as hospital inpatient and outpatient services, dialysis, hospice, skilled nursing, and home health services, IRF services, Medicare Part D services, ambulatory services, and the Medicare Advantage (MA) program (including standardized benefits). More information regarding the timing and topics if the meetings can be found here.